Matsuura, Nobuo
,
Amemiya, Shin
Sugihara, Shigetaka
Urakami, Tatsuhiko
Kikuchi, Nobuyuki
Kato, Hiroshi
Yodo, Yasuhide
Article History
Received: 6 March 2018
Accepted: 17 June 2018
First Online: 27 June 2018
Compliance and ethical standards
:
: This clinical trial was funded by Sumitomo Dainippon Pharma Co., Ltd. NM and SA are co-first authors and the chairpersons of the first and second trials, respectively, and contributed to the discussion and wrote the manuscript. SS and SA were members of the coordinating committee for the first trial and SA, SS and TU for the second trial. NM and NK are members of the safety evaluation committee for the second trial. All of these members have received honoraria from Sumitomo Dainippon Pharma. No other potential conflicts of interest relevant to this article were reported. HK and YY are employees of Sumitomo Dainippon Pharma and managed the second trial and carried out statistical analysis, respectively.
: All procedures followed were in accordance with the ethical standards of the responsible committees on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.
: Informed consent or a substitute for it was obtained from all patients included in the study.
: This study was approved by the ethics committee of the Sumitomo Dainippon Pharma (approval no. D3004001, approval date: 19 April 2011) and by the ethics committee of Saitama Medical University (approval no. 918, approval date: 24 May 2011).